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NCT03474081 · ClinicalTrials.gov registry record · Phase 4
A Comparative Study Between Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Single Inhaler Triple Therapy Versus Tiotropium Monotherapy in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 4 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 800
- Enrollment target
NCT03474081: Completed Phase 4 study, sponsored by GlaxoSmithKline.
NCT03474081 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 800 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (54% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03474081, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 800 participants
- Enrollment target
Study Summary
COPD is a progressive disease characterized by increasing obstruction to airflow and the progressive development of respiratory symptoms including chronic cough, increased sputum production, dyspnea and wheezing. Once-daily triple therapy of an Inhaled Corticosteroid/ Long-acting Muscarinic Receptor Antagonists/ Long Acting Beta-Agonist (ICS/LAMA/LABA) that is combination of FF/UMEC/VI in a single device is being developed with the aim of providing a new treatment option for the management of advanced COPD. The primary purpose of this study is to evaluate lung function and health related quality of life (HRQoL) after 84 days of treatment with a single inhaler triple therapy combination of FF/ UMEC/VI once daily via the ELLIPTA® dry powder inhaler (DPI) compared with tiotropium once daily via HANDIHALER®, in subjects with COPD. Subjects will be randomized 1:1 to receive FF/UMEC/VI or tiotropium in the morning for 84 days. Subjects will also receive albuterol/salbutamol as a rescue therapy throughout the study. Approximately 848 subjects with advanced COPD will be enrolled in the study. The total study duration will be approximately 17 weeks including, 4-week run-in period, 12-week treatment period and a 1-week follow-up period. ELLIPTA is a registered trademark of GlaxoSmithKline (GSK) group of companies. HANDIHALER and RESPIMAT are registered trademarks of Boeringher Ingelheim.
Primary Outcome
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 85 was defined as the mean of the two planned spirometry FEV1 measurements. Change from Baseline in trough FEV1 on Day 85 was calculated by subtracting Baseline FEV1 value from the trough FEV1 value on Day 85. Baseline FEV1 was defined as the mean of the two assessments made at 30 and 5 minutes pre-dose on Day 1.
Interventions
- DRUG FF/UMEC/VI
- DRUG Tiotropium
- DRUG Albuterol/salbutamol
- DRUG Placebo to match FF/UMEC/VI
- DRUG Placebo to match tiotropium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 800 participants |
| Start Date | 2018-03-29 |
| Est. Completion | 2019-07-17 |
| Phase | Phase 4 |
What the finished NCT03474081 record still lists
NCT03474081 is an interventional study that assigns participants to a tested intervention. The registered 800 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (54% higher).
The record links to 0 conditions, and to 5 interventions - of which FF/UMEC/VI is the first listed.
NCT03474081 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03474081 about?
NCT03474081 is a clinical study titled "A Comparative Study Between Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Single Inhaler Triple Therapy Versus Tiotropium Monotherapy in Subjects With Chronic Obstructive Pulmonary Disease (COPD)". COPD is a progressive disease characterized by increasing obstruction to airflow and the progressive development of respiratory symptoms including chronic cough, increased sputum production, dyspnea and wheezing. Once-daily triple therapy of an Inhaled Corticosteroid/ Long-acting Muscarinic Receptor...
What is the current status of trial NCT03474081?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 800 participants. The study started on 2018-03-29. Estimated completion is 2019-07-17.
What interventions are being tested in trial NCT03474081?
The interventions under investigation include: FF/UMEC/VI (DRUG), Tiotropium (DRUG), Albuterol/salbutamol (DRUG), Placebo to match FF/UMEC/VI (DRUG), Placebo to match tiotropium (DRUG).
Who is sponsoring clinical trial NCT03474081?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03474081's enrollment target sits among peer trials
800 99th of 2000 higher than 1,901 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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